A Randomised Phase III Study of Elacytarabine vs. Investigator’s Choice in Patients with Late Stage Acute Myeloid Leukaemia
A Randomised Phase III Study in Patients with Late Stage Acute Myeloid Leukaemia, comparing the efficacy, measured as overall survival (OS), of elacytarabine and investigator’s choice.
Clavis Pharma ASA
350 participants
Aug 17, 2010
Interventional
Conditions
Summary
This study compares the safety and effectiveness of different types of chemotherapy to treat late stage acute myeloid leukaemia. Who is it for? You can join this study if you are aged 18 years or over and have been diagnosed with acute myeloid leukaemia, for which you have undergone two or three previously unsuccessful chemotherapy regimens. Trial details In this study, participants are randomly (by chance) divided into two groups. One group will receive chemotherapy with the drug, Elacytarabine. This will be administered intravenously (into the vein) continuously for 3 days every 3 weeks. The investigator wil decide how long it is beneficial for you to receive treatment.The other group will receive one of a number of other chemotherapy regimens used to treat leukaemia. The treatment administered will be selected by the treating doctor based on your condition. Participants will be regularly monitored in order to determine the safety and effectiveness of treatment.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Elacytarabine continous infusion days 1-5, every 3 weeks, dose 2000 mg/m2/d. 1-2 treatment courses should be administered for remission induction, and 1-2 courses for consolidation. Patients who benefit from the treatment may receive repeated courses of study drug at the discretion of the investigator, even if remission is not attained.
Locations(12)
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ACTRN12611000474954